Tuesday, May 30, 2006

On May 2, the U.S. Court of Appeals for the District of Columbia issued a split opinion in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, -- F.3d -- , No. 04-5350 (PDF copy). In this case, the Alliance, supported by the Washington Legal Foundation, sought access to post phase I trial investigational new drugs on behalf of mentally competent, terminally ill adults with no alternative government approved treatment options. Under the Food Drug and Cosmetic Act, drugs cannot be sold in interstate commerce without Food and Drug Administration (FDA) approval for marketing. 21 U.S.C. § 321(p)(1). The FDA approval process involves three phases of human testing -- phase I which is a safety test on 20-80 patients; phase II which is an efficacy test on up to several hundred patients, and phase III which is an expanded trial. These trials can take seven years, according to the opinion.

The Court in a majority opinion written by Judge Rogers and joined by Chief Judge Ginsburg held in reliance on Washington v. Glucksberg, 521 U.S. 702 (1997) that the due process clause of the Fifth Amendment to U.S. Constitution protects the right of terminally ill people to access investigational new drugs that have cleared initial safety testing at phase I of the trials when the patient's doctor holds the opinion that the drug is potentially life saving, even though its efficacy has not yet been proven. The Court found that the government has not blocked access to investigational new drugs for the greater part of our Nation's history. Analogizing to the Supreme Court's opinions in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990)(holding than an individual has a due process right to refuse life sustaining treatment), as well as Roe v. Wade and Griswold v. Connecticut, the Court decided that "the key is the patient's right to make the decision about her life free from government interference." (Slip op., at 3).

The Court remanded the case to the district court for its decision on whether the FDA'spolicy restricting access to investigational new drugs with certain compassionate exceptions is narrowly tailored to serve a compelling governmental interest." I learned in law school many years ago now that it is very difficult for the goverment to satisfy the compelling interest test (as opposed to the rational basis test which is applied when there is no fundamental substantive due process right at stake.)

I found Judge Griffith's dissenting opinion quite convincing. Judge Griffith believes that the Alliance should have taken its argument to Congress rather than the courts. He disagrees that there is a fundamental right to access investigational new drugs citing a long history of state and federal regulation of drugs. "Contrary to the tradition asserted by the majority, there is a tradition of courts rejected arguments that the Constitution provides an affirmative right of access to particular medical treatments prohibited by the Government" (Dissent at 19). The dissent raises a number of important health law questions presented by the majority opinion, e.g, "If a terminally ill patient has such a right, are patients with serious medical conditions [similarly entitled]; can a patient access any drug if she believe in consultation with a physician that it is potentially life saving?" (do you remember Laetrile) and here's a question from me -- if these investigational new drugs become widely available after phase I -- why would anyone participate in a phase II or III trial where some participants receive the drug and others receive a placebo? (Trials are ethical because there is no evidence that the investigational new drug is more effective than existing treatments or the placebo.)

The D.C. Circuit, in my view, has opened a real Pandora's box, and I trust that the FDA and the Justice Department are evaluating their rehearing/appeal options.